Clinical Data
iFuse vs. Open (Smith - ASIR 2013)
Open versus Minimally Invasive Sacroiliac Joint Fusion: A Multi-center Comparison
Smith AG, Capobianco R, Cher D, Rudolf L, Sachs D, Gundanna M, Kleiner J, Mody MG, Shamie AN.
Ann Surg Innov Res. 2013 Oct 30;7(1):14.
DOI: 10.1186/1750-1164-7-14. PMCID: PMC3817574
ABSTRACT
Background: Sacroiliac (SI) joint pain is an under diagnosed source of low back pain due in part to lack of visiblepathology on radiographs and symptoms mimicking other back-related disorders. Open SI joint fusion has beenperformed since the 1920s. This technique has fallen out of favor with the introduction of minimally invasiveoptions. To date there has been no direct comparison between open and MIS SI joint fusion.
Methods: We conducted a multi-center, retrospective comparative cohort study of patients who underwent SI joint fusion using either an open surgical (OS) technique using a combination of screws and cages or a minimally invasive surgical (MIS) technique with a series of titanium plasma spray (TPS) coated triangular implants. Operative measures including surgical operating time, length of hospitalization and estimated blood loss (EBL) were collected along with demographics and medical history, surgical complications, and 12- and 24-month pain scores. Improvements in pain were compared after matching for age and gender and controlling for a history of lumbar spine fusion using repeated measures analysis of variance.
Results: Data were available for 263 patients treated by 7 surgeons; 149 patients treated with OS and 114 treated with MIS SI joint fusion. Compared to OS patients, MIS patients were on average 10 years older (mean age 57 vs. 46) and 69% of all patients were female. MIS operative measures of EBL, operating time and length of hospitalization were significantly lower than open surgery (p < 0.001). Pain relief, measured as change from baseline to 12 months in VAS pain rating, was 3.5 points lower in the MIS vs. OS group (−6.2 vs. -2.7 points, p < 0.001). When matched for age, gender and a history of prior lumbar spinal fusion, postoperative pain scores were on average 3.0 points (95% CI 2.1 – 4.0) lower in MIS vs. OS (rANOVA p < 0.001).
Conclusions: In this multi-center comparative study, patients who underwent either OS or MIS SI joint fusion showed postoperative improvements in pain score. Compared to OS patients, patients who underwent MIS SI joint fusion had significantly greater pain relief and more favorable perioperative surgical measures.
KEYWORDS: Minimally invasive surgery, Sacroiliac joint, Arthrodesis, Open surgery
Full List of Authors
Arnold Graham Smith is a paid consultant of SI-BONE Inc.
Robyn Capobianco is an employee of SI-BONE, Inc.
Daniel Cher is an employee of SI-BONE, Inc.
Leonard Rudolf is a paid consultant, ownership interest, recipient of an SI-BONE research grant, and conducts clinical research for SI-BONE Inc.
Donald Sachs is a paid consultant and conducts clinical research for SI-BONE Inc.
Mukund Gundanna is a paid consultant and conducts clinical research for SI-BONE Inc.
A Nick Shamie is a paid consultant and ownership interest in SI-BONE Inc.
Jeffrey Kleiner
Milan G Mody